Drug safety is always the primary concern in both the stage of new drug development and the post-marketing clinical application stage, and it is also the main reason for drug development failure and even post-marketing drug withdrawal. The physiologically-based pharmacokinetic (PBPK) model can not only routinely predict the human plasma pharmacokinetics, but also predict the concentration distribution of drugs in different tissues, which has become an important tool for predicting the adverse reactions of new drugs and has gradually attracted the attention of drug regulatory authorities. In this article, the latest progress and application of the PBPK model for predicting drug-induced nephrotoxicity, cardiotoxicity, and neurotoxicity are briefly reviewed to provide references for early prediction of adverse drug reactions in new drug development and rational clinical use of drugs.

Drug safety is always the primary concern in both the stage of new drug development and the post-marketing clinical application stage, and it is also the main reason for drug development failure and even post-marketing drug withdrawal. The physiologically-based pharmacokinetic (PBPK) model can not only routinely predict the human plasma pharmacokinetics, but also predict the concentration distribution of drugs in different tissues, which has become an important tool for predicting the adverse reactions of new drugs and has gradually attracted the attention of drug regulatory authorities. In this article, the latest progress and application of the PBPK model for predicting drug-induced nephrotoxicity, cardiotoxicity, and neurotoxicity are briefly reviewed to provide references for early prediction of adverse drug reactions in new drug development and rational clinical use of drugs.